Senior External Manufacturing Quality

1 semana atrás

São José dos Campos, São Paulo, Brasil J&J Brazil Tempo inteiro

Senior External Manufacturing Quality & Compliance Analyst To be based of work located at São Jose dos Campos - SP Who We Are At Kenvue, we realize the extraordinary power of everyday care.

Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENA, AVEENO, TYLENOL, LISTERINE, JOHNSON'S and BAND-AID that you already know and love.

Science is our passion; care is our talent.

Our global team is made by 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers.

With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day.

We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for youJoin us in shaping our future-and yours.

What You Will Do?Establishes and maintains quality assurance programs for External Manufacturers (EM), procedures and controls, ensuring that performance parameters of both the products and quality system elements are continually measured to drive improvement initiatives.

Administers the change control program and manages local procedures and specifications in the document control system.
Leads efforts to comply with company policies, procedures, and quality standards, as well as safety and environmental regulations.
Develops solutions to database problems of advanced scope and complexity.
Generates, identifies, and suggests improvements in significant performance trends.
Reports them to management and appropriate cross functional teams.
Ensures appropriate technical assistance in the use of information mapping technology.
Releases batches once it has been determined that all compliance and procedural requirements have been met.

Investigates, tracks and trends customer complaints and provides complaint data for quality reports including annual drug product reviews, and monthly or quarterly complaint reports.


Key Responsibilities:
This position will be responsible for the management of External Manufactures (EMs) sites with different manufacturing Technologies.

The main activities are described below:

  • Manage troubleshooting with the EMs.
  • Manage Investigation, CAPAs and Change Controls at Kenvue Systems.
  • Provide support to Investigation, CAPAs and Change Controls at the EMs quality system.
  • Ensure the accomplish of all Kenvue Quality requirement for EMs sites (oversight).
  • Perform annually Quality Reviews with EMs Sites.
  • Provide support and identify improvement opportunities internally (Kenvue Base Business) and External manufacturing sites.
  • Support Audit readiness program at the EMs site.
  • Monthly Metrics Report.
  • Be part of areas meetings and war rooms.
  • Support new products implementation or products change projects.
  • Ensure alignment will all EMQ&C practices.
  • Complaint Management.
  • Audit action Plans management.
  • Support EM Validation Process.
  • Execute External site oversight presential visitis
  • Supplier Qualification process

What We Are Looking For Education:
Graduation in Pharmacy / Engineering / Chemistry or other correlate area

Required Qualifications:
* +

  • Advanced English
  • Intermediate Spanish
  • 5 years minimum Experience in Quality or other correlated areas related to Pharma / Medical Devices and Cosmetic Industries Preferred Skills and Experience:
  • Statistical knowledge
  • Strong connection ability and able to influence
  • Able to propose innovative solutions on a dynamic environment
  • Technical Write Skills
  • Skills to communicate issues to the upper management
  • Problem solving skills
  • Presentation skills
  • Audit Experience / Qualification (ISO, ASQ, ANVISA, DIGEMID)
  • Lean Six Sigma - Green or Black belt What's In It For You
  • Competitive Benefit Package
  • Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More
  • Learning & Development Opportunities
  • Employee Resource Groups
  • This list could vary based on location/region Kenvue is proud to be an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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